UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046656 |
|---|---|
| Receipt number | R000053222 |
| Scientific Title | A study for the effect of intakes of a food ingredient on mood state in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/07/20 15:06:41 |
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Basic information
Public title
A study for the effect of intakes of a food ingredient on mood state in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
A study for the effect of intakes of a food ingredient on mood state
Scientific Title
A study for the effect of intakes of a food ingredient on mood state in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
A study for the effect of intakes of a food ingredient on mood state
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a food ingredient on mood states in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood states (trait-anxiety, perceived stress, apathy, mental health, vitality, calmness of mind)
Key secondary outcomes
Mood states (state-anxiety, depression), health-related quality of life, blood indicators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intakes of test tablets for 6 weeks
Interventions/Control_2
Intakes of placebo tablets for 6 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women in good health who are between 45 and 64 years of age at the time of obtaining consent
(2) Subjects whose first language is Japanese.
(3) Subjects who often feel irritated or anxious in daily life.
(4) Subjects who are not suspected of depression on the Beck Depression Questionnaire (BDI-II) (19 points or less)
(5) Subjects who have received two or more doses of COVID-19 vaccine and more than one week has passed since the last dose at the time of obtaining consent.
Key exclusion criteria
Subjects
(1) with high psychological health as a result of the GHQ28
(2) who showed significant fluctuations in the measured values of the major endpoints in the two pre-tests
(3) who continuously consume medicines or foods fortified with the ingredients involved in functionality
(4) who continuously take medicines or health foods to improve their mood, fatigue, stress, or sleep
(5) who regularly engage in activities aimed at improving mood, fatigue, stress, and sleep
(6) who are unable to use the prescribed applications on their smartphones or cooperate with web surveys
(7) whose working days are irregular
(8) whose life is irregular several times during the research period
(9) whose lives are scheduled to undergo major changes during the research period
(10) who are heavy drinker
(11) who are undergoing treatment for, have a history of, or are suspected of having a mental disorder
(12) who are suffering from or aware of sleep-related illnesses
(13) who have been diagnosed with chronic fatigue syndrome
(14) who may have physical deconditioning due to test foods
(15) who regularly smoke or who started smoking cessation within 12 months
(16) who have donated 200 or 400 mL of whole blood or had a blood transfusion within 3 months prior to the pre-test
(17) who have participated in other clinical trials within 1 month prior to the pre-test, or who plan to participate during the study period
(18) who have a disease that requires constant medication
(19) who are judged unsuitable as subjects by the Chief Medical Officer based on the clinical examination values
(20) who are pregnant, lactating, or planning to become pregnant or lactate during the study period
(21) who are judged to be unsuitable as subjects based on their responses to the preliminary questionnaire
(22) who work for a company that develops or manufactures functional foods, either by themselves or by a family member living with them
(23) who are judged unsuitable as subjects by the Chief Medical Officer
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Ano |
Organization
Kirin Holdings Company, Limited
Division name
Research & Development division, Kirin Central Research Institute
Zip code
2518555
Address
Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, Japan
TEL
09014360162
Yasuhisa_Ano@kirin.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakagawa |
Organization
EP Mediate Co., Ltd.
Division name
Food Department, Trial Planning Section
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
08077101146
Homepage URL
nakagawa.takashi768@eps.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kirin Holdings Company, Limited
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
0368374128
02976_Ni@kirin.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053222
